Clinical Safety Specialist

Quantum Leap Healthcare•San Francisco, CA

About The Position

The Clinical Safety Specialist supports the collection, processing, and oversight of clinical trial safety data. The role collaborates closely with Senior Clinical Safety Specialists and cross-functional partners, including Clinical Operations, Data Management, Quality Assurance, and Safety Working Groups, to ensure regulatory compliance and alignment with departmental objectives.

Requirements

Experience in clinical trial safety data collection, processing, and oversight.
Familiarity with regulatory requirements for clinical trial safety.
Ability to perform initial assessments of seriousness, expectedness, causality, and regulatory reportability.
Proficiency in entering and quality-checking data in a safety database.
Experience with MedDRA coding.
Ability to write clear, concise, and compliant case narratives.
Skill in identifying and following up on missing or unclear safety information.
Experience managing a safety mailbox and ensuring timely responses.
Ability to document, track, and action safety communications.
Experience serving as a pharmacovigilance liaison.
Ability to support Safety Working Group activities.
Experience with reconciliation between clinical and safety databases.
Ability to support the delivery of safety deliverables to partners.
Experience contributing to safety sections of reports and filings.
Ability to support audit and inspection readiness activities.
Knowledge of SOPs and Work Instructions.
Ability to identify and escalate process gaps, risks, or improvement opportunities.
Experience participating in team meetings and providing case status updates.

Responsibilities

Receive, review, triage, and process adverse event and other safety information from clinical trials in accordance with applicable regulatory requirements, QLHC SOPs, Work Instructions, and project-specific plans.
Perform initial assessments of seriousness, expectedness, causality, and regulatory reportability, escalating safety issues per defined governance and escalation pathways.
Enter, maintain, and quality-check adverse event data in the QLHC safety database, including accurate MedDRA coding and clear, concise, and compliant case narratives.
Proactively identify missing, inconsistent, or unclear safety information and conduct documented follow-up via written or verbal communication with study sites, monitors, or partners.
Monitor and manage the Clinical Safety mailbox daily to ensure timely receipt, acknowledgment, triage, and routing of safety information in compliance with regulatory timelines and internal procedures.
Ensure all safety mailbox communications are appropriately documented, tracked, and actioned, including coordination of follow-up with study sites, partners, and internal functions.
Serve as a pharmacovigilance liaison and resource to internal and external stakeholders, including Clinical Operations, Data Management, Quality Assurance, Safety Working Groups, and clinical sites, as delegated.
Support Safety Working Group activities, including agenda preparation, material compilation, safety issue tracking, and documentation of discussions, decisions, and action items.
Collaborate with Senior Clinical Safety Specialists to support reconciliation between clinical and safety databases and resolution of discrepancies in a timely and traceable manner.
Support delivery of routine and ad hoc safety deliverables to pharmaceutical partners in accordance with applicable Safety Data Exchange Agreements and contractual timelines.
Contribute to the preparation, review, and submission of safety sections of annual reports, regulatory filings, and other periodic safety deliverables, as assigned.
Support audit and inspection readiness activities, including document preparation, response drafting, and implementation of follow-up actions under supervision.
Maintain compliance with SOPs and Work Instructions.
Identify and escalate process gaps, risks, or improvement opportunities to support a robust and sustainable safety operation.
Participate in daily Clinical Safety team meetings to provide case status updates, flag risks or delays, align on priorities, and support timely decision-making and workload management.
Perform other safety-related duties as assigned to support departmental objectives and operational continuity.